Effect of Intravenous 5% Dextrose Infusion During Recovery From Anesthesia on the Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy

Insulin Resistance Clinical Trial

Official title:

Effect of Intravenous 5% Dextrose Infusion During Recovery From Anesthesia on the Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06319144
• Other study ID #: KYLL20240306-1
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: May 5, 2024

Study information

• Verified date: March 2024
• Source: Weifang Medical University
• Contact: Lin Cheng, B.S
• Phone: 17667404256
• Email: 1318216353[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to determine the effect of intravenous infusion of 5% dextrose injection during the recovery period of anesthesia for painless gastroenteroscopy on the patient's blood glucose level, incidence of hypoglycemia and time of awakening from anesthesia, postoperative vertigo, postoperative nausea and vomiting, and quality of recovery in the early postoperative period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 5, 2024
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who met the indications for Painless Gastrointestinal Endoscopy and were =18 years old; Intraoperative anesthesia was propofol compounded with dizocin intravenous anesthesia;

2. The patient or his/her guardian or immediate family members gave informed consent;

3. American Society of Anesthesiology (ASA) anesthesia risk classification = grade III.

Exclusion Criteria:

1. Patients with contraindications to sedation/anesthesia for gastrointestinal endoscopy:

e.g., severe hepatic and renal dysfunction, cardiac insufficiency;

2. Patients receiving chemotherapy and opioid treatment; patients with a history of sleep apnea hypoventilation syndrome;

3. Intravenous nutritional support within 8 hours prior to the examination;

4. Patients diagnosed with type I or type II diabetes.

Related Conditions & MeSH terms

• Insulin Resistance
• Postoperative Nausea and Vomiting
• Quality of Recovery
• Vomiting

Intervention

Other:
• 5% glucose
Patients in the experimental group were infused intravenously with 5% dextrose (500 ml/h) in the PACU.
• 0.9% Normal Saline
Patients in the control group were infused intravenously with 0.9% Normal Saline (500 ml/h) in the PACU.

Locations

Country	Name	City	State
China	Lin Cheng	Weifang	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Weifang Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative blood glucose 30min	A fingertip blood glucose concentration of <3.9 mmol/L was used as a diagnostic criterion for hypoglycemia. Severity and incidence of hypoglycemia at 0.5 hours Preoperative.	Measurements taken 0.5 hours Preoperative.
Primary	Postoperative blood glucose 30min	A fingertip blood glucose concentration of <3.9 mmol/L was used as a diagnostic criterion for hypoglycemia. Severity and incidence of hypoglycemia at 0.5 hours postoperatively.	Measured at 0.5 hours postoperatively.
Primary	Postoperative nausea and vomiting	The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade =I means that the symptom occurs. The severity and incidence of PONV at 0.5 hours postoperatively.	Measured at 0.5 hours postoperatively.
Primary	Postoperative nausea and vomiting	The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade =I means that the symptom occurs. The severity and incidence of PONV at 2 hours postoperatively.	Measured at 2 hours postoperatively.
Primary	Postoperative nausea and vomiting	The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade =I means that the symptom occurs. The severity and incidence of PONV at 6 hours postoperatively.	Measured at 6 hours postoperatively.
Primary	Postoperative nausea and vomiting	The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade =I means that the symptom occurs. The severity and incidence of PONV at 24 hours postoperatively.	Measured at 24 hours postoperatively.
Secondary	Anesthesia awakening time	The clinical routine defines the time of awakening from anesthesia as the time between the cessation of anesthesia administration and the opening of the patient's eyes on call.	Approximately 30min after surgery
Secondary	Dizziness level	The Dizziness Assessment Rating Scale (DARS) was used to assess the degree of postoperative dizziness in patients undergoing painless gastroenteroscopy.	Approximately 15min after surgery
Secondary	Dizziness level	The Dizziness Assessment Rating Scale (DARS) was used to assess the degree of postoperative dizziness in patients undergoing painless gastroenteroscopy.	Approximately 30min after surgery
Secondary	Dizziness level	The Dizziness Assessment Rating Scale (DARS) was used to assess the degree of postoperative dizziness in patients undergoing painless gastroenteroscopy.	Approximately 24hours after surgery
Secondary	Quality of postoperative recovery (QoR40)	The QoR-40 scale provides a true and valid reflection of the impact of various factors on the quality of postoperative recovery.	Approximately 24hours after surgery